Condition category
Digestive System
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
17/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr R Cunningham

ORCID ID

Contact details

Microbiology Dept.
Level 05
Derriford Hospital
Derriford
Plymouth
PL6 8DH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0185139377

Study information

Scientific title

Effect of stopping proton pump inhibitors (PPI) on the incidence of Clostridium difficile diarrhoea (CDD)

Acronym

Study hypothesis

To determine whether restricting unnecessary use of PPIs reduces the incidence of Clostridium difficile diarrhoea in hospital inpatients

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Digestive System: Diarrhoea

Intervention

Randomised controlled intervention study to determine whether restriction of PPI use to National Institute for Clinical Excellence (NICE) approved indications has an effect on subsequent incidence of Clostridium difficile diarrhoea (CDD). Interventions compared are stopping PPIs versus non stopping PPIs.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Incidence of CDD

Secondary outcome measures

Not provided at time of registration

Overall trial start date

11/03/2004

Overall trial end date

28/09/2005

Reason abandoned

Eligibility

Participant inclusion criteria

400 patients aged 65 or over admitted to hospital via Medical Assessment Unit (MAU) who are taking PPIs.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

11/03/2004

Recruitment end date

28/09/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Derriford Hospital
Plymouth
PL6 8DH
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Plymouth Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes